THE PATENTABILITY OF SECOND MEDICAL USE CLAIMS IN VIETNAM IS AGAIN QUESTIONABLE

Under the new IP Code of Vietnam, medical use claims in form of Swiss-type claims are no longer patentable.

(Published inPharmaceutical Law Insight, May 2008, p15)

Although second medical use claims had long been allowed in Vietnam, they are now again rejected for the reason of their failure to be patentable subject-matters.1

It is known to patent practitioners, especially those having experience dealing with inventions in medical and/or pharmaceutical fields, that medical method inventions are not patentable in many countries, including Vietnam. The legislative grounds for such an exclusion may vary from country to country (being an outright exclusion or being a concept regarding such methods as lacking industrial application), but the political will behind such exclusion is the legislators’ fear of creating a bar for patients to medical assistance by granting patents for such inventions, and they wish to free from any constraint all non-commercial and non-industrial medical and veterinarian activities by excluding medical methods from patent protection. Such exclusion, though saving doctors from all threat of patent infringement, constitutes a barrier for the development of the pharmaceutical industry. R&D practice in the pharmaceutical field finds it difficult and wasteful to discover new active substances for every medical purpose, thus new and inventive medical applications of a known substances has been regarded as inventions deserving patent protection in some jurisdictions. Where medical methods are excluded from patent protection like the European countries or Vietnam, a so-called second medical use or “Swiss type” claim format (use of a compound in manufacture of a medicament for treating a disease) had been a way to go around the exclusion. The original legal ground therefore is provided under the Swiss Patent Law allowing patent protection for use of known substances in manufacture of medicaments for medical purpose. The phrase “in manufacture of” used in this claim format is meant to bring about the required industrial applicability to the claims. Also, an EPO case (G05/83) set a precedent for granting European patent for a “specific and useful therapeutic indication” of known substance. The particular purpose that the EPO Board phrased as “specific and useful therapeutic indication” is to specifically differentiate this type of claim from the first medical use inventions, for which claims are usually drafted as “substance for medical purpose”.2

In such background, it is observed that the Vietnamese National Office of Intellectual Property (NOIP), while applying the new Code of Intellectual Property of Vietnam3, rejects all inventions relating to uses in general and to medical uses in particular, legally speaking for the reason that they fail to be either products or processes and hence do not constitute patentable subject-matters4. This is the first ever legal basis firmly cited by the NOIP to refuse granting patent protection for use inventions in its 25-plus-year history. The political will behind this rejection, however, resides in the public inference that patent protection of medical use inventions renders the extremely high price of drugs in the local market. It should be emphasized that such inference is not based on any serious investigation or reliable research.

The Vietnamese IP Law is seen among the rare legal systems to provide for a definition of invention.5 A trait of such definition is found in the WIPO Model Law on inventions for developing countries,6 but even this definition does not give any hint to limit inventions to products and processes only.7 Notably, the concept of invention mentioned in paragraph 1 of Article 27 the TRIPS Agreement is not strictly limited to products and processes. Although paragraphs 28 and 39 of Article 27 of the TRIPS Agreement does provide for cases where WTO member countries may exclude from patent protection certain inventions, they are not applicable to exclude use inventions in general, and medical use inventions in particular.

In practice, use inventions have generally been consistently and unquestionably treated as patentable subject-matter in different jurisdictions. Despite the fact that the US Patent Law does not specifically mention use as such among patentable inventions,10 utility patents have been granted for use inventions in the US. In Japan, the definition of “invention” does not mention uses as such.11 Moreover, the definition of “working” of inventions in the Japanese Patent Law, likewise, relates only to cases where inventions are product, process or process of manufacturing a product.12 Nevertheless, use inventions have still been patented in Japan in product-by-use claim format, process claim format or use claim format itself.13 The European Patent Convention (EPC) does not provide for any definition or list of patentable inventions, instead it merely lists patentability criteria.14 Yet, the EPO, having the authority to grant EP patents with validity in 38 European countries/states, does grant patents for use inventions in general,15 and for medical use inventions in particular by applying special provisions preserving novelty of known substances or compositions.16 So, patent protection is indeed available for use inventions in various countries independent of the facts the local law does not specifically enumerates them among patentable inventions and invention is not defined therein so as to encompass uses as such.

Thus, it is submitted that the definition of “invention” under Vietnamese patent law should be construed consistently with the global practice. The gist of this definition should be confined, if so needed, to “technical solution”, while “product or process” should not be regarded as limiting examples of “technical solution”. In such a way, uses can really be considered, as it was in the past and as it has so been at the global scale, patentable subject-matters where for example known products are used for a new purpose and hence resolving specific problems still by utilizing laws of nature.

Notwithstanding the narrow interpretation of the definition of “invention” under the current IP Code of Vietnam, it is further submitted that uses in general and second medical uses in particular should not be treated less patentable than any products or processes, unless the law provides specifically for the contrary.

Second medical use inventions have usually been regarded as the converted format of the medical method inventions where the later are excluded from patent protection, and hence the earlier should in substance be regarded as process inventions. However, this argument is merely speculation in light of the detailed articulation of “process” in the meaning of “technical solution” under current Vietnamese patent law.17 Indeed, hardly can second medical use inventions qualify as process for its lack of information defining the way to carry out the intended process, particularly due to the lack of specific steps, conditions, ingredients, manner, vehicles, etc. for carrying out the process. In this relation, it should be recalled the long existing legal fiction regarding medical method inventions as insusceptible to industrial application, and the very phrase “in manufacture of” being included in this claim format to impart the required susceptibility to industrial application,18 rather than giving any trait of a real process being carried out. On the other hand, it should be noted that process inventions in practice are not defined only by steps, conditions for carrying out the steps and starting materials, but also by the final product of the processes. It is even more important to emphasize that the final product of a process is not necessarily a tangible product as it could well be an intangible product in the sense of improvement of some condition, or an effect to something. And particularly in that sense, use invention can be a process in the meaning of technical solutions.

In a closely relevant precedent held by German Supreme Court, second medical use claims was originally regarded to belong to the category of process claims,19 and hence being eligible for utility model protection. However, the German Utility Model Act (GUMA) defines a process as “a manufacturing process generating a product” or “a working process resulting into an abstract result without having a material impact on the object to which the process is applied”.20 The German Supreme Court, in interpreting the above section, found that “the use of a drug does not generate a product but has an impact on the body”. According to this Court, the subject-matter of a second medical use claim is the suitability of a known compound for a specific new medicinal purpose, which ultimately is an inherent characteristic of the known compound. Hence, the subject-matter of such a pharmaceutical use claim is charaterised by a substance for a specific use. Consequently, the second medical use claim includes more elements of a product claim than that of a process claim. Finally, the Supreme Court concluded that a second pharmaceutical use claim corresponds to a use-limited product claim.21

Furthermore, the recently amended Article 54, especially paragraphs 4 and 5, of the European Patent Convention again confirms the attitude of the EPO and its member countries in treating pharmaceutical use claims in general, and second medical use inventions in particular, as purpose-related product inventions. This attitude was clearly articulated in the Explanatory notes of the proposal by the Swiss delegation, emphasizing that the medical use claims under amended Article 54(5) of EPC is the format of purpose-related product inventions, and their scope of protection is equivalent to that offered by the “Swiss type claim”.22

As a conclusion, it is submitted that even if the Vietnamese legislators intended to exclude from patent protections all use inventions, including medical use inventions, the Vietnamese patent law should comply with its international obligations, including those under the TRIPS Agreements. Thus, either a more specific legal basis should be present in order to reject patenting medical use inventions, otherwise patent protection should be available for these inventions in order to make the local legal system really clear, consistent, and harmonized with the international practice, and in order to render the country more attractive and competitive for investment.

*****Footnotes:1. See: New developments in patent protection for medical uses in Vietnam2. For summary on the worldwide practice and law in this respect, see The Vietnamese treatment – Protection for medical inventions, Patent World # 161, April 2004, 25-29.3. The Code of Intellectual Property of Vietnam (2005), which came into force as of July 1, 2006.4. Article 4.12 of the Code of Intellectual Property of Vietnam provides that “invention is a technical solution, in form of a product or a process, in order to resolve a specific problem by utilizing laws of nature.”5. Id.6. WIPO Model Law on inventions for developing countries (1979): “‘Invention’ means an idea of an inventor which permits in practice the solution to a specific problem in the field of technology”7. Subject to the provisions of paragraphs 2 and 3 [of Article 27 of the TRIPS Agreement], patents shall be available for any inventions, whether products or process, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.8. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.9. Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.10. 35 U.S.C. 101 Inventions patentable: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain patent therefor, subject to the conditions and requirements of this title.11. Article 2.1 (Japanese Patent Law 1999): “Invention” in this Law means the highly advanced creation of technical ideas by which a law of nature is utilized.12. Article 2.3 (Japanese Patent Law 1999): “Working” of an invention in this Law means the following acts: (i) in the case of an invention of a product, acts of manufacturing, using, assigning, leasing, importing or offering for assignment or lease (including displaying for the purpose of assignment or lease – hereinafter the same) of, the product; (ii) in case of an invention of a process, acts of using the process; (iii) in the case of an invention of a process for manufacturing a product, acts of using, assigning, leasing, importing, offering for assignment or lease of, the product manufactured by the process, in addition to the acts mentioned the preceding paragraph.13. Toshihiko Asano, Desirable ways to examine and implement use inventions, IIP Bulletin 2005, 10-16.14. Article 52.1 (European Patent Convention): European Patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.15. G05/83, point 11-12 of the conclusion: “The European Patent Convention, in general, allows both method claims and use claims but whether any activity is claimed as a method of carrying out the activity (setting out a sequence of steps) or as the use of a thing for a stated purpose (the sequence of steps being implied), is, in the opinion of the Enlarged Board, a matter of preference… Whilst, therefore, there can be non objection to “use claims” in general, the obvious objection to a patent “with claims directed to the use” being granted for “the use of a substance or composition for the treatment of the human or animal body by therapy” is that it seems to be in direct conflict with the provisions of Article 52(4) EPC, in accordance with which “methods for treatment of the human or animal body by therapy…shall not be regarded as inventions which are susceptible of industrial application” within the meaning of Article 52(4)EPC”.16. Article 54, paragraphs 4 and 5 (European Patent Convention): (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art; (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.17. Article 25.3 of Circular 01/2007/TT-BKHCN:“a process (technological procedure, method for diagnosis, forecasting, testing, treatment…) characterised by a combination of information defining a way to carry out a particular process or task specified by features (characteristics) as to order, conditions, ingredients, manner, vehicles for carrying out the manipulations in order to reach a certain purpose.”18. The Diplomatic Conference in November 2000 on the revision of the EPC, document CA/100/00 page 41.19. Dr. Alexa von Uexkull and Dr. Niels Holder, Utility Model Protection, Patent World #183 (June 2006), 23-25.20. Section 5(2) of GUMA corresponds to Art. 52(4) of the EPC.21. Supreme Court, decision of September 20, 1983, GRUR 1983729 – “Hydropyridin”22. The new Article 54(5) of the EPC eliminates any legal uncertainty on the patentability of further medical uses. It unambiguously permits purpose-related product protection for each further medical se of a substance or composition already known as a medicine. This protection is equivalent, as far as the further uses are concerned, to that offered by the “Swiss type claim”. Explanatory notes, submission by the Swiss delegation to the Diplomatic Conference in November 2000 on the revision of the EPC, document MR/18/00/e.